Government Should Focus on Patient Needs

Later this year, Americans
will be heading to the polls
to vote for candidates they
believe will make the best
decisions to help them lead safer,
healthier, more productive lives.

In fact, Americans are telling their
elected officials that one of their
highest priorities is access to quality,
affordable health care. With health
care costs continuing to escalate, it is
an issue that candidates and state
and federal government officials cannot
afford to ignore.

Increasingly, families are recognizing
that one key way to achieve better
health at lower costs is to switch to
safe, effective, and affordable generic
medicines. Today, 63% of Americans
are choosing generic medicines to fill
their prescriptions. It is not hard to
understand why: generics provide the
same medicine and the same results as
their brand counterparts, but at a significantly
lower cost.

In 2008, the generic industry will
continue to take steps to ensure that
those affordable medicines reach
patients in a timely manner. We are
working hard to let lawmakers know
how important generics are to
patients and the health care system.

We are focused on approving legislation
to create an FDA approval
pathway for biogenerics, or generic
versions of biopharmaceutical products.
Legislation would provide
patients with access to safe, effective,
and affordable life-saving medicines,
which are used to treat conditions
such as diabetes and cancer. More
than 70 organizations and governors
have joined GPhA's efforts in support
of legislation.

This year, we will face a mounting
push for extending market exclusivity
for brand biopharmaceuticals.
GPhA believes strongly that extending
market exclusivity puts brand
profits ahead of patient needs by
delaying timely access to affordable
biogenerics. If Congress is serious
about getting safe biogenerics into
the hands of patients, it must ensure
that it does not tie the generic industry's
hands by granting the brand
companies excessive market exclusivity—
which translates into longer
brand product monopolies, to the
detriment of patients.

We also are monitoring patent
reform, which is currently under
debate in Congress. Although it is
important to enhance the integrity of
the patent process, the industry is
concerned that some of the provisions
under consideration would
undermine the objective to achieve
real reform. Specifically, the industry
opposes efforts to change inequitable
conduct, which ensures that dubious
patents are not preserved, and best
mode, which is critical to promoting
efficient use of scientific resources.
Both measures are vital to bringing
affordable generics to market.

Other issues that will be at stake
include counterfeiting and pedigree
measures, authorized generics, and
free trade agreements. We have
joined with a coalition, Rx Safe-
Track, on possible anti-counterfeiting
and pedigree measures to ensure that
medicines can be traced throughout
the supply chain. On authorized
generics, we are working to close a
loophole used by brand companies to
discourage generic companies from
challenging questionable brand
patents. And on free trade agreements,
our goal is to achieve what we
did this past fall in the United
States?Peru Free Trade Agreement—
Congressional passage of an agreement
that maintains a balance
between encouraging innovation and
allowing access to generic medicines.

There is no doubt that 2008 will be
an exciting year in the political and
legislative arenas, and GPhA will be
working hard to ensure that the right
choices are made to improve
Americans' health for less.